Package Insert 1. NAME OF THE VETERINARY MEDICINAL PRODUCT AviTuberculin 30 000 Intravitally diagnostic preparation for simple tuberculinisation 2. QUALITATIVE AND QUANTITATIVE COMPOSITION OF VETERINARY MEDICINAL PRODUCT 1 ml contains: Active substances : Tuberculinum Mycobacterii avium (Tuberculinum Mycobacterium avium) min.30 000 I.U. 3. INDICATIONS Intravitally diagnosing for simple tuberculinisation. 4. TARGET SPECIES Beef cattle, pigs, horse, sheep, goat 5.DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION 0,1 ml strictly interdermally Application scheme: Cattle Simultaneous tuberculinisation means contemporary application of bovine tuberculin and avian tuberculin for simultaneous examination . Simultaneous tuberculinisation is done not rather than 42 days after interpretation of simple tuberculinisation . Tuberculines are applied intradermally on the side of neck in dose 0,1 ml, generally bovine tuberculin on the left side and avian tuberculin on the right side. In the big rearing is possible to practise simultaneous tuberculinisation nevertheless that both of allergens are applied intradermally on the one side of neck in the vertical plane in the line of frontal margin of scapula. Bovine tuberculin is applied on the border of middle and top third of the neck and avian tuberculin is applied approximately 12 cm ventrally from application place of bovine tuberculin. Listed method of allergens inoculation is recommended especially in the rearing where the application on two sides of neck presents problems with fixation of animals . Interpretation of results: Simultaneous tuberculinisation is regarded 72 hours after application of tuberculin . Both of tuberculines are regarded according to key for simple tuberculinisation by bovine tuberculin. Interpretation of tuberculinisation results for infection of Mycobacterium bovis : a) Positive – reaction number for bovine tuberculin exceed the reaction on avian tuberculin above 4 mm , or in the application place of bovine tuberculin , clinical signs such as diffuse or extensive oedema , exudation , necrosis, painfulness or inflammatory reaction of corresponding lymphatic vessels or ganglions were determined. b) Dubious – reaction on bovine tuberculin is positive or dubious if the reaction number is not higher above 4 mm as a reaction on avian tuberculin and no clinical signs are figure. c) Negative – reaction on bovine tuberculin is positive, dubious or negative , or reaction number is identical or less as avian tuberculin and in both of cases no clinical signs occur. It is recommended to do another allergologic examinations minimum 42 days after simultaneous tuberculinisation , to animals in which the results were dubious. Animals with positive or dubious results of second tuberculinisation are regarded as positive responsive on bovine tuberculin. In controversial cases control forced slaughter completed with laboratory examination of organs and lymphatic ganglions or another examinations are recommended. Pigs Intradermally tuberculinisation is done on dorsal side of ear approximately 2-3 cm from auricular base. Application dose is 0,1 ml (3000 I.U.) Evaluation of results The tuberculinisation results are read after 48 hours of application . In the case of a positive reaction characteristic inflammatory swell often following with erythema and sometimes central necrosis occurs in the place of application . In pigmented pigs it is necessary to regard inflammatory swell of skin with possible necrosis as mainly symptom. In the rearing free of tuberculosis the swell with diameter up to 20 mm is regarded as positive reaction and swell with diameter 10-20 mm is regarded as dubious result. In rearing , where the tuberculosis was acknowledged , the size of inflammatory changes up to 10 mm is regarded as positive result and inflammatory changes to 10 mm are regarded as dubious reaction. To horses 0,1ml (3000 U.I.) is applied on the side of the neck. To sheep 0,1ml (3000 U.I.) is applied after cutting of the wool from the dorsal part of the auricle. To goats 0,1ml (3000 U.I.) is applied on the side of the neck. 6. EXPIRY DATE 12 months